Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.
- The 8-Step Checklist To Write Effective Investigation Reports
- Rare Diseases: How To Leverage Social Media For Patient Analysis
- Serendipity And CDMO Catapult COVID-19 Candidate
- FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
- Medtech Innovation: 3 Strategies For Leveraging Agile Methodologies
- eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?
- Designing A Patient-Centric Digital Ecosystem: Strategies For Cell And Gene Therapy CxOs
Rare Diseases: How To Leverage Social Media For Patient Analysis
Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
Medtech Innovation: 3 Strategies For Leveraging Agile Methodologies
While medtech firms have had proven success with scaling and short bursts of innovation from special projects and acquisitions, many firms have struggled to achieve a steady stream of disruptive innovation. This article provides three strategies for leveraging agile methodologies for better innovation.
eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?
When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?
Designing A Patient-Centric Digital Ecosystem: Strategies For Cell And Gene Therapy CxOs
Cell and gene therapy (CGT) production is costly, complex, and high-risk; in part, because most supply chain and manufacturing processes involve multiple stakeholders and facilities. In the first article of this series we discussed how CGT adoption and success hinges on early planning to scale manufacturing and supply. This article describes strategies to enable a patient-centric digital ecosystem and capabilities to support CGTs before, during, and after the order life cycle.
Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book
The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.
4 Lessons For AI In Medtech: Case Studies From Breast Cancer Detection
Recent advances in artificial intelligence (AI) and machine learning, especially deep learning, are poised to help further advance many medical fields. One of the physicists involved in helping advance breast health solutions through AI shares his 4 lessons learned in working with AI in mammography technology, and those lessons can be applied to many other medtech fields.
How To Enhance “Operational Learning” In Biopharma
According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.
PHARMA OUTSOURCING WHITE PAPERS
Navigate The CMC Regulatory Landscape For Cell And Gene Therapies
The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.
Strategies For Flexible Manufacturing
Biopharmaceuticals are increasingly complex and on shorter timelines to meet patient needs. Here's an in-depth look at the latest market drivers, approaches, and technologies in flexible manufacturing.
Cell Therapy Scale-Up Strategies For Commercial Success
This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.
Lipid Formulations To Enhance Bioavailability In Early Development
To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.
Navigating Regulatory And Development Milestones
This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.
Precision Powder In Capsule Micro Dosing Accelerates Drug Product Development
Advancing active pharmaceutical ingredients (APIs) through the drug product-development lifecycle is fraught with challenges. Development timelines are tight, so it’s crucial to determine early in the process if an API is a viable candidate for clinical testing. A key tool that has emerged to address these combined issues of tight timelines and complex molecules is precision powder micro-dosing in capsules. This paper describes the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma
OUTSOURCED PHARMA CONTENT COLLECTIONS
In this collection of recent editorials, Outsourced Pharma Chief Editor Louis Garguilo wades into the noisy intersection of national and international politics, and our pharmaceutical industry, from the perspective of our main focus on drug development and manufacturing outsourcing.More Content Collections
PRODUCTS & SERVICES
SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.